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Completed

NCT Number: NCT04801784

Fluid Balance Neutralization During CRRT (Continuous Renal Replacement Therapy)

Fluid overload is associated with increased mortality in critically ill patients with acute kidney injury. Fluid balance controlled is associated with improved outcome in observational studies, and is deemed safe in interventional trials.

The objective of the study is to keep fluid balance neutral by matching the net ultrafiltration rate to fluid inputs in patients with vasoplegia, and treated with continuous renal replacement therapy (CRRT), while insuring its security using advanced hemodynamic monitoring with continuous cardiac output monitoring.

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Key information

Conditions

Fluid Overload Acute Kidney Injury Edema Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Shock Signs and Symptoms Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospices Civils de Lyon - Hôpital de la Croix Rousse

Lyon, 69004, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient 18 yo or more, affiliated to a social security system
  • Treated with vasopressors for acute circulatory failure
  • With KDIGO stage 3 acute kidney injury
  • Treated with continuous renal replacement therapy for less than 24 jours
  • Monitored with a calibrated continuous cardiac output device

Exclusion criteria

  • Treatment by ECMO (extracorporeal membrane oxygenation)
  • Active hemorrhage necessitating transfusion
  • Maintenance dialysis or renal graft recipient
  • Switch to intermittent hemodialysis is scheduled in the next 72 hours
  • Acute cerebral stroke complicated by coma and under mechanical ventilation
  • Acute fulminant hepatitis
  • Postural maneuver (passive leg raising or Trendelenburg) cannot be performed (amputation, inferior vena cava obstruction)
  • Pregnancy or lactating
  • Withdrawal or limitation of care
  • Moribund patient
  • Patient under protective measures/wardship
  • Inclusion in another trial whose main outcome is cumulative fluid balance, or whose intervention targets hemodynamic physiology, fluid balance or net ultrafiltration.
  • Patient previously enrolled in the same study

Treatment and study plan

Increased net ultrafiltration with advanced hemodynamic monitoring

Procedure

A net ultrafiltration rate of 100 ml/h or more will be applied during the first 72 hours of study participation. To insure the hemodynamic security of the intervention, it is associated with an advanced hemodynamic monitoring protocol which encompasses cardiac index, preload dependence assessment (using postural maneuvers), lactate levels and central venous pressure evaluation. The hemodynamic monitoring protocol allows the decrease or suspension of the neutral ultrafiltration rate in case of hemodynamic instability or of hemodynamic status considered at risk of worsening if net ultrafiltration rate is maintained.

Zero or near-zero net ultrafiltration

Procedure

The active control group aims to represent the present standard of care of net ultrafiltration management in the first 72 hours of study participation in patients with critical illness. This will be performed by setting the net ultrafiltration rate to 0 up to 25 ml/h.

Primary outcomes

  1. Cumulative fluid balance

    Time frame: 72 hours from study inclusion (H72)

    The cumulative fluid balance (in ml) will be calculated as the total amount of input received by the patients (including IV fluids and medications, blood products, hydration and nutrition), minus the total output over the same period of time (including urine output, net ultrafiltration, and drains). The cumulative fluid balance at H72 will be compared between study groups in alive patients at H72.

Secondary outcomes

  1. Number of hemodynamic episodes

    Time frame: 72 hours from study inclusion

    Hemodynamic instability is defined as the appearance of mottles, a mean arterial pressure < 65 mm Hg and requiring urgent intervention, a decrease in cardiac index > 15%, or tachycardia > 120 beats per minute (bpm).

  2. Number of hemodynamic episodes with preload dependence status

    Time frame: 72 hours from study inclusion

    Hemodynamic episodes defined as stated above, that were associated with preload dependence, defined as a significant increase in cardiac index when performing a postural maneuver. This test will be performed every 4 hours as part of the hemodynamic protocol

  3. Number of Major Adverse Kidney Events (MAKE)

    Time frame: 90 days from study inclusion

    MAKE is a composite criterion applied to participants, composed of either the persistence of renal impairment at Day90 (defined as a serum creatinine > 2 x baseline value), renal replacement therapy dependence at Day90, or death at Day90. A separate analysis of each components of the MAKE 90 outcome will be performed.

  4. Mean arterial pressure

    Time frame: Every 4 hours from inclusion to 72 hours after inclusion

    Repeated measurement or assessment of mean arterial pressure, cardiac index, lactatemia, and vasopressor dose will make it possible to assess the hemodynamic effect of study intervention

  5. Cardiac index

    Time frame: Every 4 hours from inclusion to 72 hours after inclusion

    Repeated measurement or assessment of mean arterial pressure, cardiac index, lactatemia, and vasopressor dose will make it possible to assess the hemodynamic effect of study intervention

  6. Lactatemia

    Time frame: Every 4 hours from inclusion to 72 hours after inclusion

    Repeated measurement or assessment of mean arterial pressure, cardiac index, lactatemia, and vasopressor dose will make it possible to assess the hemodynamic effect of study intervention

  7. Vasopressor dose administered

    Time frame: Every 4 hours from inclusion to 72 hours after inclusion

    Repeated measurement or assessment of mean arterial pressure, cardiac index, lactatemia, and vasopressor dose will make it possible to assess the hemodynamic effect of study intervention

  8. Cumulative fluid balance

    Time frame: 24 hours and day 7 from study inclusion

    The cumulative fluid balance will be calculated as stated for the primary outcome at Hours24. It will be estimated using body weight variation between inclusion and day 7.

  9. Cumulative net ultrafiltration

    Time frame: 24 hours, 72 hours and day 7 from study inclusion

    The cumulative net ultrafiltration is reported by CRRT (continuous renal replacement therapy) generators ad collected every 4 hours from inclusion to 72 hours after inclusion.

  10. Number of respiratory and circulatory failure free days

    Time frame: Day 28 of study inclusion

    Organ failure free days are defined as the number of days without organ support, and censored at 28 days of inclusion. Weaning of mechanical ventilation is defined as being free of IMV for 48 hours or more. Weaning of vasopressor is defined as being free of any vasopressor administration for 48 hours or more. Participant who die are over the 28-day period are assigned a value of 0 organ failure free days.

  11. Severity of organ failures using the SOFA score

    Time frame: from inclusion to 72 hours of study inclusion

    Organ failure severity is quantified using the SOFA score (Sepsis-related organ failure assessment), and is collected at inclusion, and daily until Hours 72. The SOFA score assesses 6 physiological systems: respiratory, circulatory, coagulation, liver, renal and neurological.

  12. PaO2/FiO2 ratio

    Time frame: 24 hours, 48 hours, and 72 hours from study inclusion

    Intensity of pulmonary hydrostatic edema will be quantified using the PaO2/FiO2 ratio variation from inclusion to Hours24, Hours48 and Hours72 of study inclusion

  13. Extravascular lung water index

    Time frame: 24 hours, 48 hours, and 72 hours from study inclusion

    Intensity of pulmonary hydrostatic edema will be quantified using the extravascular lung water index reported by the continuous cardiac monitoring device, from inclusion to Hours24, Hours48 and Hours72 of study inclusion

  14. Hospitalisation duration

    Time frame: Day 90 of study inclusion

    Hospitalisation duration will be quantified as the delay between participant admission and discharge from hospital, censored at day 90 from inclusion.

  15. Duration of stay in Intensive Care Unit (ICU)

    Time frame: Day 90 of study inclusion

    Duration of stay in ICU will be quantified as the delay between participant admission and discharge from ICU, censored at day 90 from inclusion

  16. Survival

    Time frame: Day 28 and 90 of study inclusion

    Vital status (death/alive) will be reported at D28 and D90 of study inclusion.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Hemodynamic-guided Fluid Balance Neutralization During Continuous Renal Replacement Therapy in Critically Ill Patients: the GO NEUTRAL Randomized Controlled Multi-center Study

Acronym: GO-NEUTRAL

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 17, 2021
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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